Female internal reproductive organs
Retroperitoneal lymph nodes
While Bioncise succesfully applied for MDR 2017, the certification is still ongoing due to incapacity of the Notified Body to issue the certificates. Until certification is published Bioncise benefits from the transitional provisions for certain medical devices that apply to the Spirotome and Corticore lines of products. More info in the "Dedrogation Publication".
MDR certificates download here
and a second certificate also here: